Brief Title
Fluorescence QRH-882260 Peptide Imaging in the Bile Duct
Official Title
Fluorescence QRH-882260 Peptide Imaging in the Bile Duct
Brief Summary
Patients undergoing ERCP procedure with biliary stricture will have epithelial mucosa labeled
with QRH-882260 fluorescence peptide that binds to EGFR. A custom mini-cholangioscope will be
used to image the luminal surfaces of the biliary duct that are exposed to the fluorescence
peptide. The images will be recorded and analyzed for relative fluorescence pattern and
intensity and correlated to patient diagnosis and clinical outcomes.
Detailed Description
A Phase 1b study of the safety and efficacy of a topically-administered 7-amino acid peptide
labeled with a near-infrared fluorophore Cy5 for detecting neoplastic areas of the bile duct
is proposed. The study will test the safety and efficacy of administering this agent
(QRH-882260 Heptapeptide) to human subjects undergoing clinically indicated ERCP for the
evaluation of biliary disorders.
This is a pilot study of a single study group at a single center. The investigators intend to
enroll 12 evaluable subjects. Expected enrollment is one subject every 1 month, so the study
should take 12 to 24 months to complete. The expected duration of each subject's
participation is 2 to 7 days.
Subjects will be recruited around their standard of care procedure. The endoscopists
performing study procedures are all credentialed to do these procedures at the UWMC Digestive
Health Center.
ERCP will proceed per UWMC standard of care. The endoscopists performing the procedure will
evaluate the potential risk (if any) for the subject to continue with the study procedure.
Five mL of the reconstituted QRH-882260 Heptapeptide (~100 μM) will be administered to the
site of interest through a catheter in the standard endoscope. Five minutes after QRH-882260
Heptapeptide application, the unbound peptide will be washed off using the endogator
irrigator and the residual liquid will be suctioned. Pictures with reflection-light and
fluorescence will be taken with the SFE based molecular imaging mini-cholangioscope (MC)
inserted via the instrument channel of the standard endoscope before the QRH-882260
Heptapeptide application, immediately after application and then again after the QRH-882260
Heptapeptide is rinsed.
The area of interest identified will be biopsied at the discretion of the endoscopist per
clinical care. Any specimens taken will be for clinical care only and will be sent for
routine histology per UWMC standard of care.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Treatment-related Adverse Events
Secondary Outcome
Evaluation of imaging content based on the clinical diagnosis
Condition
Cholangiocarcinoma
Intervention
QRH-882260 Heptapeptide
Study Arms / Comparison Groups
QRH-882260 Heptapeptide
Description: Five mL of reconstituted (with sterile 0.9% NaCl) QRH-882260 Cy-5-labeled heptapeptide
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
1
Start Date
April 22, 2019
Completion Date
August 21, 2020
Primary Completion Date
August 21, 2020
Eligibility Criteria
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the
following criteria:
1. Male or female, aged 18 to 65
2. Scheduled for outpatient ERCP
3. Understands English and is interested in participating
4. Provides signed and dated informed consent form
5. Willing to comply with all study procedures and be available for the duration of the
study
Exclusion Criteria:
1. Sleep apnea or respiratory problems
2. Pregnant or trying to conceive
3. Known allergy or negative reaction to components of the study product(s)
4. On active chemotherapy or radiation treatment
5. Anything that, in the opinion of the investigator, would place the individual at
increased risk or preclude the individual's full compliance with or completion of the
study
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Michael Saunders, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03438435
Organization ID
HUM00130597
Responsible Party
Principal Investigator
Study Sponsor
D. Kim Turgeon, MD
Collaborators
University of Washington
Study Sponsor
Michael Saunders, MD, Principal Investigator, Clinical Professor of Medicine
Verification Date
December 2020